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It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted. This comprises knowing of proposed changes as soon as announced, and being well prepared to accommodate them. Expected to be implemented by late 2018 – the functionality tests section of USP Chapter <381> (Elastomeric Closure for Injections) will be removed, and greatly expanded functionality tests will be incorporated in new USP Chapter <382> (projected title: Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems).
Chapter <382> will address fitness-for-intended-use functionality requirements for the following packages and delivery systems: (a) vials, bottles, needle-based injection systems, blow-fill sealed containers, dental cartridges, pen injectors and plastic containers for IVs; (b) corresponding elastomeric components; and (c) corresponding drug products. Functionality tests are also proposed to include syringe plunger break force, guide force and plunger seal integrity as well as syringe tip cap and needle shield tests. Chapter <382> is not self-contained – it will incorporate elements of new USP Chapter <1382> (projected title: Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems). Chapter <1382> will include discussion of fitness-for-intended-use testing, with guidance for test sample preparation, test population, procedures, data interpretation, and reporting. Chapter <1382> will also contain many relevant ISO and USP references.
The sum of all these changes is to enhance patient safety – through increased focus on testing of packaging and delivery systems at a higher system-level, including elastomeric component interactions with interfacing components and drug products. West continues to have a laser-focus on understanding the latest in the ever-changing regulatory landscape and proud to be first-to-market with advanced testing capabilities and methods to best support customers.
For more information about current and upcoming industry guidance, please visit the Industry Trends/ Regulatory section of West’s Knowledge Center here.
Component processing is a source of risk and variability, especially for loose particulate and silicone oil that can compromise quality, putting patients at risk. To simplify drug development and streamline manufacturing, pharmaceutical companies can select cartridge plungers and lined seals in a ready-to-use format.
It is an exciting time to be in the Cell and Gene therapy industry. The astounding growth and development we have witnessed in the cell & gene therapy industry over the last decade is bringing life-changing therapies to the patients who have been so anxiously awaiting them. <br /><br />At the same time, as with any new drug class, challenges that may not have been considered during the drug development phase may suddenly show up and stand in the way of overcoming that last hurdle: Packaging and delivering your precious new molecule to the patient.
In 2012, West rolled out a new global branding initiative that included a new tagline: By Your Side for a Healthier World<sup>TM</sup>. What does that mean? Every day, injectable drugs and vaccines are administered to improve the health of millions of patients around the world. And every day, West works by the side of its health care partners to design and manufacture drug packaging and delivery systems that will bring those drugs and vaccines from concept to the patient more efficiently, reliably and safely. This has been West’s legacy since the Company was founded in 1923.